Photo story: A dossier assessment is produced
To illustrate the production of a dossier assessment and to show the people behind IQWiG's reports:
This was the idea behind our first photo story, which we prepared in 2019 and posted on our Twitter account in early 2020.
The disease and the drug of this exemplary assessment within the context of early benefit assessments according to the German Act on the Reform of the Market for Medicinal Products (AMNOG) are fictitious. However, the processes are presented as realistically as possible. The participants really work in the respective departments and units – and use their real names!
With "chronic cough", we chose a widespread disease that can be well illustrated and that is not as fear-evoking as cancer. The story described here can also be accessed as a Twitter thread.
Thread: How is a dossier assessment conducted? This is what we will show here in real time over the next 13 weeks for a fictitious new drug. Project Manager Vanessa will lead through the #IQWiGfotostory. #WhyWeDoResearch Infografik: Was sind Dossierbewertungen?
Today, a new commission was received from the Federal Joint Committee (G-BA) with the question: Does the new "HustenWeg" show added benefit in chronic coughs? The Department Head decides: Vanessa will be project manager, Katrin supervisor. #IQWiGphotostory www.g-ba.de/bewertungsverfahren/nutzenbewertung/
The clock is ticking: Everything has to be ready in 3 months. Quickly form a team, prepare a schedule and print out the manufacturer dossier on which the assessment is based. Module 5 of the dossier (see figure) is confidential. #IQWiGfotostory www.g-ba.de/themen/arzneimittel/arzneimittel-richtlinie-anlagen/nutzenbewertung-35a/faqs/
According to the 4-eyes principle, Susanne and Gini select 5 external experts from our database who are particularly familiar with chronic cough. At the same time, they look for affected patients to answer our questions about their disease. #IQWiGfotostory FAQs for external experts
Week 2: Documentation specialist Annette examines the documents submitted in the dossier. The manufacturer refers to 2 studies. We have to check more closely whether both are basically suitable for our benefit assessment. #IQWiGfotostory
Information specialist Marco checks whether the manufacturer has reported all relevant studies and publications. The procedure for dossier assessments is described in our methods paper (Sections 2.1.3 and 3.3.3). #IQWiGfotostory General Methods
Discussion with supervisor Katrin: In both studies, "HustenWeg" was compared with the correct standard therapy. But according to its approval status, it may only be used after pre-treatment. We have to consider this when checking the relevance of the studies. #IQWiGfotostory
Week 3: kick-off of the project group. The patients received different pre-treatments in the studies. We have questions as to whether the respective pre-treatment was clinically appropriate. We will clarify these questions with the external expert. #IQWiGfotostory
Statistician Mandy checks whether the data were correctly analysed. Health economist Min checks the case numbers and cost information in the dossier. And an expert gets in touch; IQWiG (Director Jürgen Windeler) signs a contract with her. #IQWiGfotostory
Week 4: Based on the literature, the external expert confirms our opinion that the patients were correctly pre-treated. We determine the endpoints for the assessment. Unfortunately, the data on quality of life are rather incomplete. #IQWiGfotostory infographic: patient-relevant endpoints
Week 5: Is quality of life better with "HustenWeg" than with standard therapy? If too much study data is missing, the answer to this important question remains uncertain. Statistician Mandy estimates how great this risk of bias is. #IQWiGfotostory
Week 6: Team meeting. The evaluation of the two studies showed: Both are relevant to the assessment. They are also so similar that we can combine them in a meta-analysis. That's good; two studies are more meaningful than one. #IQWiGfotostory
Week 7: A patient with a chronic cough participates in the assessment via the German Federal Working Group of Self-Help Organizations. The patient questionnaire that he fills in tells us which endpoints are particularly important for him. #IQWiGfotostory Contributing the patients' perspective
Week 8: There is a subgroup effect: older people have more side effects with the new drug than with standard therapy. We do not see a difference in younger people. We have to determine the added benefit for older and younger people separately. #IQWiGfotostory
We consider the pros and cons of the new drug. It yields better results than standard therapy. But stronger side effects in older people limit its added benefit. Due to sparse data, it is hardly possible to draw a conclusion on quality of life. #IQWiGfotostory
Week 10: Project manager Vanessa continues to write the draft report at full speed. In between, she consults with Min from the Health Economics Unit, to ensure that, for example, the abbreviations are identical in all chapters. #IQWiGfotostory
Week 11: Supervisor Katrin and Gregor from the Quality Assurance Unit check the report for content errors. Highly focussed, each word of the report is scrutinized again. #IQWiGfotostory
Week 12: Jürgen from the Information Management Unit discovers an updated Summary of Product Characteristics on standard therapy for the disease. Now we have to quickly check: Will we have to make changes to our assessment? #IQWiGfotostory
Project manager Vanessa and her team compare the old and new Summary of Product Characteristics: How much do we have to change in our assessment in the last week? Fortunately, only one item needs to be slightly adjusted. #IQWiGfotostory
Week 13: Jochen from the Technical Editing Unit checks the report format and produces a PDF. Susanne writes the health information for "HustenWeg". Andrea discusses the press release with the Institute’s Management. #IQWiGfotostory
Volker sends the report to the contracting agency (Federal Committee = G-BA). Nelli and Johannes publish it on our website. From now on, comments can be submitted. In 3 months, the G-BA will decide on the added benefit of "HustenWeg". #IQWiGfotostory
Finished! But Vanessa hardly has time to take a deep breath; the next assessment is coming up. #IQWiGfotostory